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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
28/03/2025 Mallinckrodt Pharmaceuticals
Ireland
SPECGX LLC 21117 CODEINE SULFATE USP POWDER 2007-11-30 Active II Complete 2014-08-04 2014-07-28
28/03/2025 Mallinckrodt Pharmaceuticals
Ireland
MALLINCKRODT INC 5233 CODEINE SULFATE 1984-02-17 Inactive II N/A